In each region, regional haemovigilance and transfusion safety coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
At the request of the Agence nationale de sécurité du médicament et des produits de santé or the Director General of the regional health agency, or on his own initiative, the regional haemovigilance and transfusion safety coordinator shall obtain from the relevant haemovigilance and transfusion safety correspondent(s) any information that blood or health establishments collect and hold in application of this chapter. On the basis of this information, the coordinator…
I.-Each blood establishment is required to collect and keep, for each unit of labile blood product which it prepares, the following information: 1° The identification of the donation of blood or blood components from which the unit was obtained and the identification of the donor ; 2° The results of the biological analyses and screening tests carried out on the donation; 3° The identification of the blood establishment to which…
At the request of the Agence nationale de sécurité du médicament et des produits de santé, the blood establishment shall collect and keep all the information necessary for haemovigilance and transfusion safety to which it has access and which relates to : 1° Scheduled autologous transfusions in which the establishment has participated ; 2° Pre-transfusion and, where appropriate, post-transfusion examinations carried out on the patient; 3° The storage, for subsequent…
Health establishments send their referring blood establishment the information mentioned in II of article R. 1221-36 and in 2° of article R. 1221-37. Decisions by the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French Agency for the Safety of Medicines and Health Products) taken after consultation with the Etablissement français du sang (French Blood Establishment) and the Armed Forces Blood Transfusion Centre…
In each blood establishment, a haemovigilance and transfusion safety correspondent is responsible for ensuring, under the authority of the person in charge: 1° Collecting and keeping the information mentioned in articles R. 1221-36 to R. 1221-38 , ensuring its quality and reliability; 2° Reporting, under the conditions and in accordance with the procedures set out in articles R. 1221-49 to R. 1221-49-4, any serious adverse reaction occurring in a blood…
Each public or private healthcare establishment is required to collect and keep the following information for each unit of labile blood product distributed or issued to it for a hospitalised patient: 1° The identification number of the unit prepared in accordance with the national coding system approved by the Agence nationale de sécurité du médicament et des produits de santé ; 2° Identification of the product code in accordance with…
At the request of the Agence nationale de sécurité du médicament et des produits de santé, the establishments mentioned in the first paragraph of Article R. 1221-40 shall collect and keep all the information relating to haemovigilance and transfusion safety to which they have access and which concerns : 1° Scheduled autologous transfusions ; 2° Pre-transfusion and, where appropriate, post-transfusion examinations carried out on the patient; 3° The administration, as…
The referring blood establishment sends the establishments mentioned in the first paragraph of article R. 1221-40, the information relating to 1° and 2° of the same article and, where applicable, 2° of article R. 1221-41. Decisions by the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French Agency for the Safety of Medicines and Health Products), taken after consultation with the Etablissement français…
I.-In each of the establishments mentioned in the first paragraph of article R. 1221-40, a haemovigilance and transfusion safety correspondent is responsible for ensuring : 1° Reporting, under the conditions and according to the procedures set out in articles R. 1221-49 and R. 1221-49-2, any adverse reaction occurring in a recipient of labile blood products, as well as any serious incident ; 2° Collecting and storing the information mentioned in…
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75001, Paris France
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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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